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Device Recall Sterling Diagnostics, Inc. Enzymatic Cholesterol (Trinder/CODCEH)
Model / Serial
Cholesterol, CAT No. 2145-L, Lot No. 14551, Expiry: 11/18, Manufactured: 11/04/15
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Domestic: MI Foreign: Phillipines VA/DOD: None
Product Description
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Manufacturer
Sterling Diagnostics, Inc.
1 Event
Recall of Device Recall Sterling Diagnostics, Inc. Enzymatic Cholesterol (Trinder/CODCEH)
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Manufacturer
Sterling Diagnostics, Inc.
Manufacturer Address
Sterling Diagnostics, Inc., 36645 Metro Ct, Sterling Heights MI 48312-1009
Manufacturer Parent Company (2017)
Sterling Diagnostics Inc
Source
USFDA
Language
English
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